Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients

NCT ID: NCT01605890

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-12-31

Brief Summary

The HIV-2 is less common ie 1-2 million people in West Africa. HIV-2 does have the same sensitivity to antiretroviral treatment (ART) compared to HIV-1. The ART strategies that are appropriate for the HIV-1 infection are not as effective for HIV-2. Classical triple therapy including PI is less effective for HIV-2. Also, the choice of ARTs in a second line treatment is limited. The first line optimal treatment has to be defined by a prospective and randomized evaluation of other strategies. The primary endpoint will be adapted to the specificity of the HIV-2 infection. The 1st step is to define, with a phase II clinical trial, whether a strategy including 2 NRTIs and raltegravir, as an alternative strategy to the classical triple therapy, shows an immunovirological response, at least, as good as the one obtained with the triple therapy. The hypothesis is that the low ART response observed in HIV-2 infection is due to a low virological strength of the ARTs used and that the combination of 2 NRTIs and raltegravir should show a therapeutic success of at least 50% at week 48.

Conditions

HIV-2 Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

raltegravir / emtricitabine / tenofovir disoproxil fumarate

Group Type: EXPERIMENTAL

emtricitabine / tenofovir disoproxil fumarate / raltegravir .

Intervention Type: DRUG

emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.

raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.

Interventions

emtricitabine / tenofovir disoproxil fumarate / raltegravir .

emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.

raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• age ≥18 years
• HIV-2 mono infection, confirmed by ELISA and Western Blot test or Immunoblot,
• antiretroviral treatment-naive, whatever the duration and indication of prior treatments,
• indication to treatment, with at least one of the following criteria : type B or C events, CD4 lymphocytes count below 500/mm3 at screening-visit or CD4 lymphocytes count decrease of at least 50 cell/µL/year over the last 3 years with the last CD4 lymphocytes count within -/+ 10 % of the nadir, plasma HIV-2 RNA load over or equal to 100 copies/mL at screening-visit,
• Pneumocystis prophylaxis if CD4 lymphocytes count below 200/mm3, combined to a toxoplasmosis prophylaxis in case of a positive toxoplasmosis serology,
• French residency for at least one year,
• Written informed consent, signed by the participant and the investigator (at the latest on the screening-visit and prior any study related intervention)
• Affiliate or beneficiary of a social security system (State Medical Assistance is not a social security scheme).

Exclusion Criteria

• Absence of effective contraception method(women),
• Pregnancy, breastfeeding or wish for pregnancy during the trial,
• Curative treatment of a progressive opportunistic infection not compatible with those evaluated in the present study,
• Malignant or tumorous affection requiring chemotherapy or radiotherapy,
• Decompensated cirrhosis,
• Viral hepatitis C with a Metavir score over F2,
• Hemoglobinemia below 7g/dL, polynuclear neutrophils below 500/mm3, platelets below 50 000/mm3, creatinine clearance below 50 mL/mn, transaminase, alkaline phosphatase or bilirubin over 2.5N,
• Contraindication to one of the excipients of study treatments,
• Insuline-dependent diabetes mellitus not well controlled (with glycated haemoglobin (HbA1C) over 7%),
• Long-term corticosteroid treatment (more than 3 weeks of treatment),
• Judicial protection, legal guardianship,
• Participation in other therapeutic trial or comprising an exclusion period ongoing at the time of the screening-visit.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophie Matheron, Pr

Role: STUDY_CHAIR

Hopital Bichat-Claude Bernard

Locations

Hôpital Bichat-Claude Bernard

Paris, , France

Countries

France

References

Matheron S, Descamps D, Gallien S, Besseghir A, Sellier P, Blum L, Mortier E, Charpentier C, Tubiana R, Damond F, Peytavin G, Ponscarme D, Collin F, Brun-Vezinet F, Chene G; France REcherche Nord&Sud Sida-Hiv Hepatites (ANRS) 159 HIV-2 Trial Study Group. First-line Raltegravir/Emtricitabine/Tenofovir Combination in Human Immunodeficiency Virus Type 2 (HIV-2) Infection: A Phase 2, Noncomparative Trial (ANRS 159 HIV-2). Clin Infect Dis. 2018 Sep 28;67(8):1161-1167. doi: 10.1093/cid/ciy245.

Reference Type: DERIVED

PMID: 29590335 (View on PubMed)

Other Identifiers

ANRS 159 VIH-2

Identifier Type: -

Identifier Source: secondary_id

2011-005038-20

Identifier Type: -

Identifier Source: org_study_id